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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K882383
Device Name MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
Applicant
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Applicant Contact VICTOR J WEDEL
Correspondent
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Correspondent Contact VICTOR J WEDEL
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received06/09/1988
Decision Date 11/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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